International Institute for Advanced Pharmaceutical Manufacturing (I2APM)
Lead Research Organisation:
University of Strathclyde
Department Name: Inst of Pharmacy and Biomedical Sci
Abstract
The EPSRC Centre for Innovative Manufacturing for Continuous Manufacturing and Crystallisation is concerned with establishing new collaborations on the development of novel continuous manufacturing technologies to improve understanding of particle formation and to exploit this knowledge to enhance the manufacture of particles with specific beneficial properties. This has significant potential given the importance of particulate processing across many fine chemical industries including agrochemicals, pharmaceuticals, dyes, pigments and energetic materials.
In partnership with the US-based National Science Foundation Engineering Research Center for Structured Organic Particulate Systems, we propose to create the International Institute for Advanced Pharmaceutical Manufacturing with the goal of advancing the science and technology of integrated primary and secondary continuous manufacturing of pharmaceutical products. The aims of this project are to identify specific activities mapped onto the areas of mutual interest and start to agree forward exchanges, engage with industry and develop specific plans for joint meetings, researcher and faculty exchanges, collaborative research, and training activities that will benefit the wider community in both collaborating countries. In addition, the scope of a Mock Submission, the regulatory process by which new drugs are approved for use, will be developed by engaging jointly with UK/EU and US regulators and industry to agree on the framework that would ensure the impact of academic contributions on addressing the regulatory challenges for the adoption of continuous manufacturing.
The proposed links with international experts will lead to accelerated progress of integrating continuous manufacturing processes into the high value chemical sector, raise profile of UK-based research, and ultimately enhance the opportunities for high quality, collaborative research outcomes.
In partnership with the US-based National Science Foundation Engineering Research Center for Structured Organic Particulate Systems, we propose to create the International Institute for Advanced Pharmaceutical Manufacturing with the goal of advancing the science and technology of integrated primary and secondary continuous manufacturing of pharmaceutical products. The aims of this project are to identify specific activities mapped onto the areas of mutual interest and start to agree forward exchanges, engage with industry and develop specific plans for joint meetings, researcher and faculty exchanges, collaborative research, and training activities that will benefit the wider community in both collaborating countries. In addition, the scope of a Mock Submission, the regulatory process by which new drugs are approved for use, will be developed by engaging jointly with UK/EU and US regulators and industry to agree on the framework that would ensure the impact of academic contributions on addressing the regulatory challenges for the adoption of continuous manufacturing.
The proposed links with international experts will lead to accelerated progress of integrating continuous manufacturing processes into the high value chemical sector, raise profile of UK-based research, and ultimately enhance the opportunities for high quality, collaborative research outcomes.
Planned Impact
The main beneficiaries from the research engagement proposed in this application will be the personnel in each of the respective Centres forming the International Institute. They will benefit from increased exposure and increased level of engagement with a view to driving forth their own research ideas as part of larger global mission to transform the current practises of pharmaceutical manufacture. Ultimately who will benefit from this Institute is the international pharmaceutical manufacturing sector and regulatory bodies. Therefore the beneficiaries will range from who is directly involved in the institute to those who are associated with the research outcomes.
| Description | The I2APM was a collaborative network programme which allowed our research teams at EPSRC CMAC in the UK to work collaboratively with international partners in the US. This then led to expansion of the network to RCPE in Austria. By working collaboratively, I2APM was able to develop current practice and make suggestions for new continuous manufacturing methods and how they might be deployed and regulated. Whilst the network has now ended, many of the original team have continued to work together. Some of the US team of experts are now working at universities in the UK and have had successful EPSRC funding bids with I2APM partners - see Further Funding section. A significant piece of work in these current projects is focussed around digital research involving modelling and data, and I2APM allowed us to establish ways of sharing digital assets which we continue to do today. |
| Exploitation Route | Some of the materials and process modelling work carried out by researchers on international placements are now being regularly within integrated digital workflows used in the development of new medicines. In some instances, the models have been validated within the pharmaceutical sector and are currently being refined based on performance and feedback. |
| Sectors | Chemicals,Pharmaceuticals and Medical Biotechnology |
| Description | Through the I2APM network, CMAC have worked with Center for Structured Organic Particulate Systems (C-SOPS) in the US to create the following document: Draft Current Recommendations for Implementing and Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing. The document has been shared with industry, the public and the FDA. More broadly, some of I2APM's approaches in digital manufacturing and data sharing between centres have become more commonplace within the pharma sector and there have been several collaborative research projects (UKRI and Innovate UK) which have continued to explore and build on approaches I2APM were promoting at the time of the award. Discussions about how data can best serve the development of new medicines and support R&D within the sector are increasingly important as data-driven AI approaches continue to mature and original I2APM partners continue to focus on and drive research in these areas. Update in 2022: The further funding of projects has been reported in the common outcomes for this award. Of particular note is the Digital Design and Manufacture of Amorphous Pharmaceuticals (DDMAP) award (EP/W003295/1). This award was part of the CMAC Portfolio of projects when the EPSRC Centre for Innovative Manufacturing for Continuous Manufacturing and Crystallisation (CIM) (EP/I033459/1) award was active. During 2021 CMAC reached its 10-year anniversary as a result of the CIM and Future Continuous Manufacturing and Advanced Crystallisation Research Hub (EP/P006965/1) funding, as well as the aligned portfolio of activity. At the celebration online event in November 2022, a forward strategy for the portfolio of projects was published. The CMAC Hub, that followed from the CIM and aligned portfolio including this award, has a role to act as a National Centre and as such has aligned with key policy. This includes alignment with MMIP mission to support the UK to become a leading force in manufacturing innovation, ABPI's Manufacturing vison for the UK, The Made Smarter Report, FDA vision for Global Pharma. CMAC strategy includes aiming to achieve greater speed, quality, agility, security and sustainability, in pharmaceutical manufacturing and communicating and engaging around the need for advanced pharmaceutical manufacturing, analytics and industrial digital technology development. The need for skilled people to address the gap in Digital Transformation and Data-Driven Research has been highlighted. The UK has supported the portfolio of aligned projects underpinned by the Hub investment. The CMAC Skills pillar starts to address the requirements of the talent pipeline, and our industry partners have noted how the doctoral training at CMAC produces uniquely skilled people. Queens Anniversary Prize was awarded to University of Strathclyde for Excellence and Innovation in Advanced Manufacturing in early 2022. CMAC and MMIC were highlighted in the case supporting the award as Examples of Excellence and Innovation. A further ISCMP event was held in London in 2018 and online version went ahead in 2021. |
| First Year Of Impact | 2007 |
| Sector | Chemicals,Government, Democracy and Justice,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| Impact Types | Policy & public services |
| Description | CMMI-EPSRC - Right First Time Manufacture of Pharmaceuticals (RiFTMaP) |
| Amount | £1,543,632 (GBP) |
| Funding ID | EP/V034723/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 08/2021 |
| End | 08/2024 |
| Description | Digital Design Accelerator Platform to Connect Active Material Design to Product Performance |
| Amount | £1,800,000 (GBP) |
| Funding ID | 41299 |
| Organisation | Innovate UK |
| Sector | Public |
| Country | United Kingdom |
| Start | 03/2020 |
| End | 05/2021 |
| Description | Digital Design and Manufacture of Amorphous Pharmaceuticals (DDMAP) |
| Amount | £1,251,700 (GBP) |
| Funding ID | EP/W003295/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2021 |
| End | 03/2025 |
| Description | International Institute of Advanced Pharmaceutical Manufacturing - Events Workstrand |
| Organisation | Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | As part of the I2APM Events workstrand, CMAC are working with C-SOPS and RCPE to organise an I2APM international symposium, which will be held at the Technology and Innovation Centre at the University of Strathclyde on 30th Nov 2016. The symposium will be an event open to CMAC, C-SOPS and RCPE where the staff and students from all three centres will come together to learn about research being carried out across all institutions.This will be done with oral, poster and networking sessions, as well as researcher sandpits to establish some areas of complementary collaboration and propose further researcher exchanges. In addition to the symposium, face to face meetings with I2APM members from C-SOPS and RCPE who have visited CMAC have been organised, along with monthly meetings via teleconference for each of the 4 workgroups (research, training, regulatory and events) and meetings for the executive and academic boards |
| Collaborator Contribution | C-SOPS and RCPE are working with CMAC to help organise the I2APM symposium |
| Impact | Face to face meetings with I2APM members from C-SOPS and RCPE who have visited CMAC have been organised, along with monthly meetings via teleconference for each of the 4 workgroups (research, training, regulatory and events) and meetings for the executive and academic boards |
| Start Year | 2015 |
| Description | International Institute of Advanced Pharmaceutical Manufacturing - Events Workstrand |
| Organisation | Research Center Pharmaceutical Engineering (RCPE) GmbH |
| Country | Austria |
| Sector | Private |
| PI Contribution | As part of the I2APM Events workstrand, CMAC are working with C-SOPS and RCPE to organise an I2APM international symposium, which will be held at the Technology and Innovation Centre at the University of Strathclyde on 30th Nov 2016. The symposium will be an event open to CMAC, C-SOPS and RCPE where the staff and students from all three centres will come together to learn about research being carried out across all institutions.This will be done with oral, poster and networking sessions, as well as researcher sandpits to establish some areas of complementary collaboration and propose further researcher exchanges. In addition to the symposium, face to face meetings with I2APM members from C-SOPS and RCPE who have visited CMAC have been organised, along with monthly meetings via teleconference for each of the 4 workgroups (research, training, regulatory and events) and meetings for the executive and academic boards |
| Collaborator Contribution | C-SOPS and RCPE are working with CMAC to help organise the I2APM symposium |
| Impact | Face to face meetings with I2APM members from C-SOPS and RCPE who have visited CMAC have been organised, along with monthly meetings via teleconference for each of the 4 workgroups (research, training, regulatory and events) and meetings for the executive and academic boards |
| Start Year | 2015 |
| Description | International Institute of Advanced Pharmaceutical Manufacturing - Regulatory Workstrand |
| Organisation | Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | As part of the I2APM regulatory workstrand, CMAC are working with Center for Structured Organic Particulate Systems (C-SOPS) in the US to create a Continuous Manufacturing Regulatory Guidance document. Input into this document from CMAC academics and industry partners was sent to C-SOPS in December 2015. This document was sent out by C-SOPS to industry for comment in Jan 2016, and will be sent out to public for comment in March 2016 |
| Collaborator Contribution | C-SOPS have initiated the creation of this document and are taking the lead on its circulation. RCPE are also inputting into this document in a similar manner to CMAC. |
| Impact | Continuous Manufacturing Regulatory Guidance document has been drafted |
| Start Year | 2015 |
| Description | International Institute of Advanced Pharmaceutical Manufacturing - Regulatory Workstrand |
| Organisation | Research Center Pharmaceutical Engineering (RCPE) GmbH |
| Country | Austria |
| Sector | Private |
| PI Contribution | As part of the I2APM regulatory workstrand, CMAC are working with Center for Structured Organic Particulate Systems (C-SOPS) in the US to create a Continuous Manufacturing Regulatory Guidance document. Input into this document from CMAC academics and industry partners was sent to C-SOPS in December 2015. This document was sent out by C-SOPS to industry for comment in Jan 2016, and will be sent out to public for comment in March 2016 |
| Collaborator Contribution | C-SOPS have initiated the creation of this document and are taking the lead on its circulation. RCPE are also inputting into this document in a similar manner to CMAC. |
| Impact | Continuous Manufacturing Regulatory Guidance document has been drafted |
| Start Year | 2015 |
| Description | International Institute of Advanced Pharmaceutical Manufacturing - Research Workstrand |
| Organisation | Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | As part of the I2APM research workstrand, a joint research project is underway between CMAC and Center for Structured Organic Particulate Systems (C-SOPS) in the US. The project aims to investigate how modifications at the crystallisation stage of API production translate to behaviour in the secondary formulation stage. Batches of paracetamol of different particle sizes are being made at CMAC using continuous crystallisation and will be shipped to C-SOPS for secondary processing. Flowsheet models will be developed to produce batches of API with different variables eg size, agglomeration, and this research theme will investigate if changing these variables has an effect on the properties of the drug product tablets. In addition to this, researcher exchanges have been arranged between CMAC to C-SOPS, with a CMAC researcher visiting C-SOPS at Purdue for 2 months in March - April. Further exchanges are planned for later in 2016 and 2017 |
| Collaborator Contribution | C-SOPS will perform characterisation tests on the paracetamol batches mentioned above. They will then press batches of tablets and perform dissolution and physical testing, with an aim to investigate how modifications at the crystallisation stage of API production translate to behaviour in the secondary formulation stage. |
| Impact | Research is currently ongoing |
| Start Year | 2015 |
| Description | International Institute of Advanced Pharmaceutical Manufacturing - Research Workstrand |
| Organisation | Research Center Pharmaceutical Engineering (RCPE) GmbH |
| Country | Austria |
| Sector | Private |
| PI Contribution | As part of the I2APM research workstrand, a joint research project is underway between CMAC and Center for Structured Organic Particulate Systems (C-SOPS) in the US. The project aims to investigate how modifications at the crystallisation stage of API production translate to behaviour in the secondary formulation stage. Batches of paracetamol of different particle sizes are being made at CMAC using continuous crystallisation and will be shipped to C-SOPS for secondary processing. Flowsheet models will be developed to produce batches of API with different variables eg size, agglomeration, and this research theme will investigate if changing these variables has an effect on the properties of the drug product tablets. In addition to this, researcher exchanges have been arranged between CMAC to C-SOPS, with a CMAC researcher visiting C-SOPS at Purdue for 2 months in March - April. Further exchanges are planned for later in 2016 and 2017 |
| Collaborator Contribution | C-SOPS will perform characterisation tests on the paracetamol batches mentioned above. They will then press batches of tablets and perform dissolution and physical testing, with an aim to investigate how modifications at the crystallisation stage of API production translate to behaviour in the secondary formulation stage. |
| Impact | Research is currently ongoing |
| Start Year | 2015 |
| Description | International Institute of Advanced Pharmaceutical Manufacturing - Training Workstrand |
| Organisation | Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | As part of the I2APM training workgroup, CMAC are collaborating with Research Center Pharmaceutical Engineering (RCPE) in Austria and the Center for Structured Organic Particulate Systems (C-SOPS) in the US to collate training material from all 3 centres. The aim is to produce a training package of teaching material from CMAC, RCPE and C-SOPS, in different aspects of continuous manufacturing which can be offered to industry. Training material from CMAC, RCPE and C-SOPS has been collated and this material is currently being mapped onto different categories. Overlaps and gaps in training will be identified from this and going forward, training packages will be formulated. A training day will be held for CMAC researchers on 1st Dec 2016 to trial some of this training, and work is underway to plan for this. |
| Collaborator Contribution | C-SOPS and RCPE are contributing as per the section above, by collating training material from each centre and formaulating training packages alongside CMAC |
| Impact | A database of training has been collated with all training in continuous manufacturing which is offered by each of the 3 centres |
| Start Year | 2015 |
| Description | International Institute of Advanced Pharmaceutical Manufacturing - Training Workstrand |
| Organisation | Research Center Pharmaceutical Engineering (RCPE) GmbH |
| Country | Austria |
| Sector | Private |
| PI Contribution | As part of the I2APM training workgroup, CMAC are collaborating with Research Center Pharmaceutical Engineering (RCPE) in Austria and the Center for Structured Organic Particulate Systems (C-SOPS) in the US to collate training material from all 3 centres. The aim is to produce a training package of teaching material from CMAC, RCPE and C-SOPS, in different aspects of continuous manufacturing which can be offered to industry. Training material from CMAC, RCPE and C-SOPS has been collated and this material is currently being mapped onto different categories. Overlaps and gaps in training will be identified from this and going forward, training packages will be formulated. A training day will be held for CMAC researchers on 1st Dec 2016 to trial some of this training, and work is underway to plan for this. |
| Collaborator Contribution | C-SOPS and RCPE are contributing as per the section above, by collating training material from each centre and formaulating training packages alongside CMAC |
| Impact | A database of training has been collated with all training in continuous manufacturing which is offered by each of the 3 centres |
| Start Year | 2015 |
| Description | Researcher placement - CMAC to C-SOPS |
| Organisation | Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | Researcher placement - CMAC researcher visited C-SOPS (Purdue) for 2 months in March - April 2016 |
| Collaborator Contribution | Hosted CMAC researcher and added to knowledge base through training |
| Impact | enhanced student experience and increase of knowledge base for department |
| Start Year | 2016 |
| Description | Researcher placement - CMAC to C-SOPS |
| Organisation | Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | 2 x CMAC PhD. students visited C-SOPS (Rutgers) from 30th Sept - 28th Oct 2017 |
| Collaborator Contribution | Hosted CMAC researcher and added to knowledge base through training |
| Impact | enhanced student experience and increase of knowledge base for department |
| Start Year | 2017 |
| Description | Researcher placement - CMAC to RCPE |
| Organisation | Research Center Pharmaceutical Engineering (RCPE) GmbH |
| Country | Austria |
| Sector | Private |
| PI Contribution | CMAC PhD student visited RCPE in Graz for 2 months in Feb-March 2017 |
| Collaborator Contribution | Hosted CMAC researcher and added to knowledge base through training enhanced student experience and increase of knowledge base for department |
| Impact | enhanced student experience and increase of knowledge base in the department |
| Start Year | 2017 |
| Description | Researcher placement - CMAC to RCPE |
| Organisation | Research Center Pharmaceutical Engineering (RCPE) GmbH |
| Country | Austria |
| Sector | Private |
| PI Contribution | CMAC PhD. visited (RCPE) in Graz from 28th July - 3rd Sept |
| Collaborator Contribution | Hosted CMAC researcher and added to knowledge base through training |
| Impact | enhanced student experience and increase of knowledge base for department |
| Start Year | 2017 |
| Description | Researcher placement - CMAC to RCPE |
| Organisation | Research Center Pharmaceutical Engineering (RCPE) GmbH |
| Country | Austria |
| Sector | Private |
| PI Contribution | CMAC PDRA visited Heidi Gruber-Woefler (RCPE) in Graz from 28th Apr - 15th May 2017 |
| Collaborator Contribution | Hosted CMAC researcher and added to knowledge base through training |
| Impact | enhanced student experience and increase of knowledge base for department |
| Start Year | 2017 |
| Description | C-SOPS - I2APM Emerging Pharmaceutical Manufacturing Summit in Malta |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Policymakers/politicians |
| Results and Impact | The Emerging Pharmaceutical Manufacturing Summit was hosted by C-SOPS (Center for Structured Organic Particulate Systems) in conjunction with I2APM The summit brought together first and second wave technology adopters and academics, along with a diverse group of regulators, to stimulate further dialogue and adoption of continuous manufacturing of pharmaceuticals. |
| Year(s) Of Engagement Activity | 2017 |
| Description | I2APM International Symposium |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Postgraduate students |
| Results and Impact | The first I2APM International Symposium and Training Day, hosted by CMAC, took place in the Technology and Innovation Centre at the University of Strathclyde in Glasgow on 30th Nov-1st December 2016. Researchers and academics from RCPE, C-SOPS and CMAC participated. The event was opened in 30th November with talks from Prof Johannes Kinast (RCPE - centre director), Prof Alberto Cuitino (C-SOPS - research director), and CMAC Industrial Director Craig Johnston, who gave overviews of each centre, while CMAC Centre Manager Andrea Johnston provided an I2APM update. The other delegates each presented a talk on their research and exhibited posters before participating in discussions and social activities with the goal of initiating new collaborations between the I2APM centres |
| Year(s) Of Engagement Activity | 2016 |
| URL | https://www.i2apm.org/events.htm |
| Description | I2APM International Training Day |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Postgraduate students |
| Results and Impact | As part of the I2APM International Symposium, the I2APM training workgroup held a day of training on 1st December 2016 with sessions from C-SOPS, RCPE and CMAC. Training sessions were given to academics and PhD students from CMAC, RCPE and C-SOPS on various aspects of continuous manufacturing from each of the 3 centres Training sessions were a mixture of presentations, interactive sessions and group activity workshops A researcher networking session was used to discuss collaborative research projects, and a total of 11 proposals for projects were obtained as a result. |
| Year(s) Of Engagement Activity | 2016 |
| URL | https://www.i2apm.org/training.htm |